Events

Device Recall Crystal Metal Miller Disposable Blades 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Penlon, Ltd. (Fmly East Healthcare) 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    58820
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3213-2011
  • 사례 시작날짜
    2011-03-10
  • 사례 출판 날짜
    2011-09-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100372
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Laryngoscope, rigid - Product Code CCW
  • 원인
    Disposable laryngoscope blades incorrectly labeled with wrong size.
  • 조치
    Penlon Ltd ( frmly East Healthcare ) sent an " Urgent Field Safety Notice" dated March 7, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed to check their stock with expiry dates between August 2010 to July 2015, and ensure that the sizes written on the blades, inner plastic bags, and the carton all match. Please complete the reply form below and send to the address provided. If you have any stock where the sizes on the bags, blades, and carton do not match, quarantine the blades and contact Penlon using the information below. For further questions please call 44 1235 547093.

Device

Device Recall Crystal Metal Miller Disposable Blades
  • 모델명 / 제조번호(시리얼번호)
    All lots with expiration dates between August 2010 and July 2015
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) including the states of CA, VA and WI., and the countries of Belgium, Ireland, France, Netherlands, Norway, Portugal, Switzerland, UK, Hong Kong, Greece, Bahrain and China.
  • 제품 설명
    Crystal Metal Miller Disposable Blades (sizes 0 art no: 50676 and 00 part no 50647 || Disposable laryngoscope blades
  • Manufacturer
    Penlon, Ltd. (Fmly East Healthcare)

Manufacturer

Penlon, Ltd. (Fmly East Healthcare)
  • 제조사 주소
    Penlon, Ltd. (Fmly East Healthcare), Abingdon Science Park, Barton Lane, Abingdon United Kingdom
  • 제조사 모회사 (2017)
    BPL Medical Technologies Pvt Ltd.
  • Source
    USFDA